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Abdominoperineal Resection clinical trials

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NCT ID: NCT04334421 Active, not recruiting - Rectal Cancer Clinical Trials

APEMESH- Preventing Perineal Complications After Abdominoperineal Resection

Start date: April 3, 2020
Phase:
Study type: Observational

Abdominoperineal resection leaves an empty space to be filled by mesh or musculocutaneus flap. Several studies have reported over 30% morbidity with perineal wound healing after abdominoperineal resection. Preoperative radiotherapy is a strong predictor for perineal complications. Musculocutaneus flaps and use of biological mesh seem to minimize perineal morbidity. The role of omentoplasty at APR is controversial. Previous studies on synthetic mesh repair on perineum are almost lacking.

NCT ID: NCT04324567 Recruiting - Clinical trials for Locally Advanced Rectal Cancer

Inflammation After Laparoscopic Robot-assisted Surgery for Locally Advanced Rectal Cancer

APR-IMM
Start date: October 9, 2019
Phase:
Study type: Observational

The intention of the study is to explore metabolic and inflammatory parameters in the pelvis and systemically after abdominoperineal resection (APR) for locally advanced rectal cancer (LARC) in patients that have received radiation therapy before surgery. In this study the inflammatory response after laparoscopic robot-assisted APR for LARC will be compared to results obtained in a recent cohort of patients operated with open APR for LARC, which will serve as the control population.

NCT ID: NCT04004650 Recruiting - Rectal Cancer Clinical Trials

Gluteal Turnover Flap for Closure of the Perineal Wound After Abdominoperineal Resection for Rectal Cancer

BIOPEX2
Start date: June 28, 2019
Phase: N/A
Study type: Interventional

Background: About 700 patients per year undergo an abdominoperineal resection (APR) for distal rectal cancer (Dutch Colorectal Audit 2016).Neoadjuvant (chemo)radiotherapy is often used to further improve locoregional control. Morbidity after APR is substantial and mainly consisting of perineal wound problems in about 35% of the patients. lf primary healing of the perineal wound after APR doesn't occur, secondary healing can take up to one year, and there is even a small proportion of patients in whom a chronic perineal wound or fistula persists after one year. During this long period, intensive wound care is necessary. This results in a heavy burden on both patient and health care resources. Objective: The high morbidity rate of the perineal wound has resulted in a continuing discussion on how to close the perineal defect after APR. Our research group recently published the BIOPEX-study (NL42094.018.12), in which 104 patients were randomized between primary perinea! wound closure and biological mesh closure of the pelvic floor after APR with preoperative radiotherapy for rectal cancer. Similar uncomplicated perineal wound healing rate at 30 days (Southampton wound score < 2) was found: 63% versus 66%, respectively. The hypothesis behind this negative trial result is related to the perineal dead space between the skin and the biological mesh. Fluid will accumulate in this dead space with the risk of secondary contamination and abscess formation, leading to wound dehiscence and purulent discharge. Autologous tissue flaps have been suggested to improve perineal wound healing based on several cohort studies. At least in the Netherlands, these flaps are used only for selected patients with the large defects and highest risk of wound problems, because of the more extensive surgery with added surgical trauma and operative time, and associated donor site morbidity. For these reasons, primary perineal closure (control arm of BIOPEX) is still the standard of care in the Netherlands. A gluteal turnover flap (GT flap) is a small transposition flap trom the unilateral adjacent perineal skin and subcutaneous fat, which is flipped into the perineal dead space, and stitched with the de-epithelialised dermis to the contralateral pelvic floor remnant. Subsequently, the perineal subcutaneous fat and skin are closed over the flap in the midline, thereby not adding a donor site scar. A small pilot study trom our group showed that this is a promising solution for routine perineal closure after APR. Study design: In this multicenter single blinded study, eligible patients will be randomized between pelvic floor reconstruction using a GT flap (intervention arm) and primary closure of the perineal defect (standard arm). The perineal wound healing will be evaluated at 14 days and 1, 3, and 6 months post-operatively using the Southampton wound scoring system by an independent observer.

NCT ID: NCT03799939 Recruiting - Clinical trials for Rectal Adenocarcinoma

Chimney Trial of Parastomal Hernia Prevention

Start date: February 5, 2019
Phase: N/A
Study type: Interventional

Chimney trial is designed to compare the effectiveness and safety of specifically designated polyvinylidene fluoride mesh (PVDF, Dynamesh IPST) to controls in a multi center, randomized setting.

NCT ID: NCT03392584 Recruiting - Infection Clinical Trials

Detection and Inflammatory Characterization of Deep Infection After Surgery for Locally Advanced Rectal Cancer With Microdialysis Catheters

Start date: October 1, 2016
Phase:
Study type: Observational

The intention of the study is to explore metabolic and inflammatory parameters in the pelvis after abdominoperineal resection for locally advanced rectal cancer in patients that have received radiation therapy before surgery.

NCT ID: NCT02841293 Recruiting - Clinical trials for Abdominoperineal Resection

Cost-utility of Two Strategies of Perineal Reconstruction After Abdominoperineal Resection for Anorectal Carcinoma

GRECCAR-9
Start date: February 7, 2021
Phase: N/A
Study type: Interventional

Abdominoperineal resection performed for anorectal tumors leaves a large pelvic and perineal defect causing a high rate of morbidity of the perineal wound (40 - 60 %). Biological meshes offer possibility for a new standard of perineal wound reconstruction. Perineal filling with biological mesh is expected to increase quality of life by reducing perineal morbidity.

NCT ID: NCT02163785 Recruiting - Rectal Cancer Clinical Trials

Abdominoperineal Extra-Elevators Rectal Resection for Cancer: Prone Position vs. Supine Position

APPRO
Start date: June 2014
Phase: N/A
Study type: Interventional

Prospective multicenter randomized controlled trial comparing the prone vs. the supine position of the perineal time of the Miles operation in patients with advanced rectal cancer. Primary objective: - Pathological circumferential resection margin Secondary objectives: - 5 year oncological outcomes - Morbimortality rates - Surgical specimen quality - Perineal hernia incidence